ALACOVID Study for Vaccinated Subjects

Inclusion criteria

• Male & female aged ≥ 18 years and ≤70 years.
• Subjects with documented proof of 1st dose of vaccination within 3 months of planned 2nd dose. (If government of India implements booster dose then subjects needs to have a documented proof of 2nd dose)
• Subjects planning to have 2nd /3rd dose of COVID-19 vaccine (Covishield/ Covaxin). (If government of India implements booster dose then subjects planning to have a 3rd dose of vaccine will be included in this study)
• Subject willing and able to provide a written informed consent

Exclusion criteria

• Subjects with anemia (male: <12 g/dl, females: <11 g/dl)
• Subjects with more than 2.5 times upper limit of ALT & AST parameters.
• Subjects not willing to stop intake of any vitamin/s or mineral/s supplements during the trial except for those allowed in the study.
• Subjects with acute symptomatic COVID-19 infection indicated by fever, dry cough and severe respiratory distress.
• Subjects with SpO2 < 90%.
• Subjects with history of genetic disorders.
• Subjects with history of:

• Anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine
• Immediate or delayed-onset anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food-items etc.
• Pregnancy & Lactation:

a. Pregnant & Lactating women have not been part of any COVID-19 vaccine clinical trial so far. Therefore, women who are pregnant or not sure of their pregnancy; and lactating women should not receive COVID-19 vaccine at this time

• Provisional / temporary contraindications:

• Persons having active symptoms of SARS-CoV-2 infection.
• SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma
• Signs of acute infection or illness
• Hospitalized patients due to any illness.
• Subjects with known history (diagnosed case) of porphyria, or chronic serious liver disease, kidney disease or heart problems.
• Subjects with frequent complaints of cold, fever, cough.
• Subjects with irritable bowel syndrome.
• Subjects who are frequent travelers or are planning to travel.
• Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral administration.
• Subjects with known allergy to 5-ALA containing foods (spinach, shitake mushroom, octopus, baker's yeast, wine, vinegar, sake less).
• Subjects on vitamin D supplements
• Males and females of reproductive potential who have not agreed to use an adequate method of contraception during the study

• For females, adequate birth control methods will be defined as: hormonal contraceptives, intrauterine device or double barrier contraception, i.e., condom

+ diaphragm, condom or diaphragm + spermicidal gel or foam.

• For males, adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
• For females, menopause is defined as one year without menses; if in question, a follicle-stimulating hormone of >40 U/ml must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable.
• Subjects who are unable or unwilling to comply with requirements of the clinical trial.
• Participation in any other clinical trial of an experimental treatment for COVID-19.
• Subjects having any other family member participating in this study.
• Subjects who may be excluded at the Investigator's discretion.